FDA Registration
Active
🇺🇸 United States
Kuro Medical
Reg #: 3017496797
·
FEI: 3017496797
·
Expires 2026
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- Kuro Medical
- Registration Number
- 3017496797
- FEI Number
- 3017496797
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7625 Golden Triangle Dr Ste G
- City
- Eden Prairie
- State
- MN
- ZIP
- 55344
- Country
- US
Owner / Operator
- Firm Name
- One Life Sciences, Inc.
- Operator Number
- 10078335
- Address
- 7625 Golden Triangle Dr, Ste G
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
- Correspondent
- Matt Kyle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gastrointestinal Motility System, Capsule | NYV | Class 2 | Gastroenterology, Urology | No | 2025-07-01 |
| Transcranial Magnetic Stimulator | OBP | Class 2 | Neurology | No | 2026-03-31 |
| Elastomer, Silicone Block | MIB | Class 2 | Ear, Nose, Throat | No | 2025-09-03 |
| Shunt, Peritoneal | KPM | Class 2 | Gastroenterology, Urology | No | 2025-04-16 |
| Catheter, Ventricular, General & Plastic Surgery | GBS | Class 1 | General, Plastic Surgery | No | 2025-04-16 |
Proprietary Names
ATMO Gas Capsule System
AMPA One System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)